Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

Gastric Cancer Clinical Trial

— P-HDFL-DI  

Official title:

Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00166881
• Other study ID #: 57M9
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 4, 2013
• Start date: June 2000
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.

Description:

1. To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen

2. To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy

3. To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients

4. To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed gastric adenocarcinoma

2. Measurable or evaluable disease

3. No previous C/T

4. Age 16 ~ 75 years

5. Karnofsky Performance Status of 60%

6. 4 weeks after R/T

7. Adjuvant C/T: the last dosing of C/T 6 months before enrollment

8. WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl

Exclusion Criteria:

1. CNS metastasis

2. Patients receive concomitant anti-cancer C/T or R/T

3. Patients who are pregnant and with an expected life expectancy less than 3 months

4. Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel-Irinotecan
Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks

Locations

Country	Name	City	State
Taiwan	Department of Oncology, National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		Five years	No
Secondary	Objective response rates (CR, PR)		Confirmed objective response after 4 weeks	Yes